Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer - Full Text View

Sponsor:	Bayer
Collaborator:	ONYX Pharmaceuticals
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00073307

Purpose

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: Sorafenib (Nexavar, BAY 43-9006) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Overall survival [ Time Frame: Till the end of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate Progression-free Survival (PFS) [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
To evaluate the best overall response rate [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
To assess changes in the patient's health-related quality of life [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
Safety - (Adverse event assessment, Vital signs, Laboratory values) [ Time Frame: every 3 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: Yes ]
Safety - Electrocardiogram (ECG) [ Time Frame: Screening Visit and End of Treatment Visit ] [ Designated as safety issue: Yes ]

Enrollment:	905
Study Start Date:	November 2003
Estimated Study Completion Date:	October 2009
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 2: Placebo Comparator	Drug: Placebo Placebo
Arm 1: Experimental	Drug: Sorafenib (Nexavar, BAY 43-9006) Multi Kinase Inhibitor

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
Patients who have adequate coagulation, liver and kidney functions

Exclusion Criteria:

Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Patients with a history or presence of metastatic brain or meningeal tumors
Patients with seizure disorder requiring medication (such as anti-epileptics)
History of organ allograft or bone marrow transplant of stem cell rescue
Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
Patients who have three or more of the following:
1. ECOG performance status greater than or equal to 2,
2. Abnormally high lactate dehydrogenase,
3. Abnormally high serum hemoglobin,
4. Abnormally high corrected serum calcium,
5. Absence of prior nephrectomy

Excluded therapies and medications, previous and concomitant:

Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanates
Significant surgery with 4 weeks of start of study
Investigational drug therapy during or within 30 days
Concomitant treatment with rifampin or St. John's Wort
Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073307

Show 121 Study Locations

Sponsors and Collaborators

Bayer

ONYX Pharmaceuticals

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

#PL#N. Engl. J. Med. 356 (2) 125- 134 (2007) ISSN:0028-4793 This link exits the ClinicalTrials.gov site

#PL#PubMed. This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34.

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11213
Study First Received:	November 19, 2003
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00073307 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Renal Cell Cancer (RCC)
Cancer

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009